Data / Medical devices / System, X-Ray, Fluoroscopic, Image-Intensified / Germany
FDA-registered makers of System, X-Ray, Fluoroscopic, Image-Intensified in Germany: 5 establishments
5 establishments in Germany are registered with the FDA to make System, X-Ray, Fluoroscopic, Image-Intensified (product code JAA). 3 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, X-Ray, Fluoroscopic, Image-Intensified
- Product code
- JAA
- Country
- Germany
Makers of System, X-Ray, Fluoroscopic, Image-Intensified in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Philips Medical Systems DMC GmbH | Hamburg, Germany | Complaint file establishment, Specification developer | 5 | January 11, 2024 | 0 | 6 | 0 | api.fda.gov |
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 5 | June 3, 2011 | 0 | 0 | 0 | api.fda.gov |
| PAUSCH Medical GmbH | ERLANGEN Bavaria, Germany | Exporter to the US, Manufacturer | 2 | April 12, 2018 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthineers AG | KEMNATH Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ziehm Imaging GMBH | Nuernberg, Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.